FRAZER, Pa., May 1 /PRNewswire-FirstCall/ -- A Cephalon, Inc. Phase 3 clinical trial presented today at the 59th Annual Meeting of the American Academy of Neurology in Boston highlights data demonstrating that FENTORA(R) (fentanyl buccal tablet) [C-II] is beneficial for the treatment of breakthrough pain in patients with neuropathic pain who are already taking opioids around-the clock to manage their persistent pain. This study marks the first time an opioid has been evaluated in patients with breakthrough pain associated with chronic neuropathic pain.
“This study provides strong evidence that opioids like FENTORA may be useful in managing breakthrough pain in patients with chronic neuropathic pain,” said Dr. David Simpson, Professor of Neurology at Mount Sinai Medical Center and primary author of this study. “With FENTORA, patients experienced statistically significant and clinically meaningful improvements in pain control and expressed a preference for this medication over the opioid they had previously been prescribed to manage their breakthrough pain.”
Breakthrough pain -- a component of chronic pain -- is a flare of moderate-to-severe pain that occurs in the context of controlled persistent pain and is characterized by rapid onset, moderate-to-severe intensity, and relatively short duration. An estimated 74 percent of patients with controlled persistent pain from noncancer chronic pain conditions, including neuropathic pain, will experience breakthrough pain with a median onset of 10 minutes. In this patient population, breakthrough pain episodes can typically last 60 minutes. FENTORA, which is approved for the management of breakthrough pain in patients with cancer who are already taking and who are tolerant to opioids for their underlying persistent cancer pain, is designed to provide early-onset analgesia via a chemical reaction that enhances fentanyl absorption across the inner lining of the cheek. Cephalon is pursuing clinical development of FENTORA in breakthrough pain associated with conditions other than cancer, including chronic neuropathic pain, and expects to file a supplemental New Drug Application this year. FENTORA is not approved for use in these conditions.
The multi-center study evaluated FENTORA in adult patients with chronic neuropathic pain who were diagnosed with a variety of conditions including diabetic peripheral neuropathy, traumatic injury, postherpetic neuralgia and complex regional pain syndrome (CRPS) -- a chronic condition caused by a nerve disorder that occurs at the site of injury, often a fractured arm or leg. All patients were already receiving various around-the-clock opioid medications for persistent pain, and short-acting opioids for their one to four episodes of breakthrough pain a day.
The open label titration phase of the study enrolled 103 patients who were individually titrated to a dose that provided adequate pain relief for at least two of three breakthrough pain flares. Of these, 102 patients received at least 1 dose of FENTORA and 80 patients (78 percent) identified a successful dose with acceptable side effects. Only six patients (6 percent) withdrew from the study due to lack of efficacy. In the randomized, placebo- controlled, double-blind treatment phase in which all patients were exposed to both FENTORA and placebo, data from 75 patients (95 percent of patients who reached a successful dose) were evaluable for efficacy. Key study findings include:
-- The primary efficacy measure, the Sum of Pain Intensity Differences from 5 though 60 minutes (SPID60), demonstrated significantly higher scores compared to placebo (9.6 +/- 0.75 vs. 5.7 +/- 0.72, p<0.0001). -- Reduction in pain intensity (PI) and pain relief (PR) was significantly greater with FENTORA than placebo at 10 minutes (p<0.05, p=0.0005, respectively) and maintained throughout the 120 minute evaluation period (p<0.0001 for both PI and PR). -- Significantly more episodes treated with FENTORA showed clinically meaningful reductions in pain intensity (greater or equal to 33 percent reduction at 10 minutes, p=0.008; greater or equal to 50 percent improvement at 15 minutes, p=0.0057). These improvements persisted throughout the 120 minute measurement period (p<0.0001). -- The majority of patients preferred FENTORA over their previous breakthrough pain treatment, rating it good or excellent with respect to onset of action (72 percent), ease of administration (78 percent), and convenience of use (79 percent). -- FENTORA was generally well-tolerated. Adverse events associated with FENTORA in the clinical trial were typical of those seen with opioids, with the exception of mild and transitory application site abnormalities (8 percent). The most common side effects included nausea (13 percent), dizziness (13 percent), drowsiness (10 percent), and vomiting (5 percent). Of the 102 patients included in the safety evaluation, 12 withdrew from the study due to adverse events during the titration phase; none were due to application site abnormalities. There were no reports of respiratory depression or other serious adverse events related to FENTORA in this study.
“This study shows the important role FENTORA can play in the management of breakthrough pain in patients with neuropathic conditions who are already receiving opioids for their persistent pain,” said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. “There is a need to identify additional treatment strategies for this patient population, and these data demonstrate that FENTORA may be an option for breakthrough pain associated with chronic neuropathic pain.”
IMPORTANT WARNINGS AND SAFETY INFORMATION
FENTORA contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. FENTORA can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing FENTORA in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion. Schedule II opioid substances which include morphine, oxycodone, hydromorphone, oxymorphone, and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression.
FENTORA is indicated for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least 60 mg of oral morphine/day, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Because life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients, FENTORA is contraindicated in the management of acute or postoperative pain. This product is not indicated for use in opioid non-tolerant patients.
Patients and their caregivers must be instructed that FENTORA contains a medicine in an amount which can be fatal to a child. Patients and their caregivers must be instructed to keep all tablets out of the reach of children (see Information for Patients and Their Caregivers contained within the prescribing information for disposal instructions).
Due to the higher bioavailability of fentanyl in FENTORA, when converting patients from other oral fentanyl products, including oral transmucosal fentanyl citrate (OTFC and Actiq(R)), to FENTORA, do not substitute FENTORA on a mcg per mcg basis and adjust doses as appropriate (see DOSAGE AND ADMINISTRATION contained within the prescribing information).
FENTORA is intended to be used only in the care of opioid tolerant cancer patients and only by healthcare professionals who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.
Full prescribing information about FENTORA, including boxed warning, is available from www.FENTORA.com or Cephalon Professional Services and Medical Information (1-800-896-5855)
Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and marketing of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction. Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company’s headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. Cephalon’s European headquarters are located in Maisons-Alfort, France.
The company’s products in the United States include: PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA, TRISENOX(R) (arsenic trioxide) injection, VIVITROL(R) (naltrexone for extended-release injectable suspension), GABITRIL(R) (tiagabine hydrochloride), ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II]; numerous products are marketed internationally. Full prescribing information on its U.S. products is available at http://www.cephalon.com or by calling 1-800-896-5855.
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs; development of potential pharmaceutical products, including any future indications for FENTORA; interpretation of clinical results, including the results of the clinical trials of FENTORA in patients with neuropathic pain; prospects for regulatory approval; market prospects for its product; sales and earnings guidance; and other statements regarding matters that are not historical facts. You may identify some of these forward- looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Cephalon’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.
Cephalon, Inc.
CONTACT: Media, Stacey Beckhardt of Cephalon, Inc., +1-610-738-6198,mobile, +1-610-247-0212, sbeckhar@cephalon.com; or Catherine Collier forCephalon, Inc., +1-212-886-2214, ccollier@cooneywaters.com; or investors,Robert (Chip) Merritt of Cephalon, Inc., +1-610-738-6376,officecmerritt@cephalon.com
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